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Pioneering ARC-EX continues to progress

ONWARD tech secures further FDA approvals ahead of expected launch later this year



Medtech pioneer ONWARD has secured further approvals from the FDA for use of its ARC-EX device in effectively supporting more aspects of spinal cord injury (SCI). 

ONWARD has been granted Breakthrough Device Designation status from the US Food and Drug Administration (FDA) for its technology to address bladder control, alleviation of spasticity and blood pressure regulation in people with SCI.

It now has a total of eight Breakthrough Device Designations, as the company continues with its innovative approach and commitment to developing therapies for people living with SCI and paralysis. 

And it adds further to the potential of ARC-EX – which remains on track for commercial launch later this year – in delivering life-changing outcomes through movement and function for patients.

“Bladder control, spasticity and blood pressure dysregulation are three of the many challenges people with spinal cord injury must manage in order to navigate their daily lives,” said Dave Marver, CEO of ONWARD. 

“We are proud of our eight total Breakthrough Device Designations from the FDA, which validate the significant unmet needs of the SCI community and the pioneering nature of our work.” 

ARC-EX is an external, non-invasive platform consisting of a stimulator and wireless programmer. 

Positive top-line data were reported in 2022 from the company’s first pivotal study, called Up-LIFT, which evaluated the ability for ARC-EX Therapy to improve upper extremity strength and function. 

“Functional recovery once deemed impossible may now be in reach,” said Dr Marco Baptista, chief scientific officer of the Christopher and Dana Reeve Foundation, after results of the study showed its efficacy in delivering improvements in upper body strength and function. 

The LIFT Home study also revealed its potential in being used remotely. 

ONWARD is now preparing its regulatory submissions for the US and Europe, with the expectation it may be approved for commercialisation in late 2023. 

In addition to the ARC-EX, ONWARD has also created the implantable ARC-EX, which demonstrated its impact through the STIMO-BRIDGE study, which enabled three participants to regain the ability to walk, swim and run after living with paralysis for a long period of time.